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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05843136
Other study ID # CAEE: 52035721.9.0000.0171
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2022
Est. completion date March 15, 2023

Study information

Verified date April 2023
Source Universidade Federal do Oeste do Para
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.


Description:

Low back pain is characterized by pain and represents a change in health that affects mainly adults, although electrostimulation represents an important tool in the treatment of patients with chronic nonspecific low back pain, the clinical efficacy of the interferential current used in physiotherapy still lacks reinforcement for clinical validation. In this way, the present study evaluated whether the use of interferential current contributes to reducing chronic low back pain and analyzed whether the electrotherapeutic protocol can benefit the physical functionality of patients with chronic low back pain. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. Data analysis was performed using the JAMOVI 2.2.5 software. Our data showed that individuals with interferential current showed significant improvement in pain relief, as well as in the functional pattern of pain improvement. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 15, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals of both genders - Aged between 18 and 65 years - Voluntarily sought the Clinic's physiotherapy service - Low back pain for more than 12 weeks - Medical request and diagnosis of low back pain with or without pain radiating to the lower limbs - Immunization against COVID 19. - Signature of the free detailed term clarified. (FDTC) Exclusion Criteria: - Physiotherapy treatment carried out in a period equal to or less than 8 weeks before starting the research - Reporting any contraindications inherent to the use of electrotherapy - Participants with fractures or spinal surgery - Involved in a legal medical dispute - Diagnosis of fibromyalgia - Patients with flu-like symptoms during the research period - Participants who have more than 2 (two) absences will be excluded from the research.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
physiotherapy treatment
this is an interventional study of the use of 3 physiotherapy treatment techniques in order to evaluate the effectiveness of interferential current in relieving chronic low back pain

Locations

Country Name City State
Brazil Luiz Paulo Sobral Pereia Santarém Para

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal do Oeste do Para Fundação Amazônia de Amparo a Estudos e Pesquisas FAPESPA

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isolated comparative evaluation method, before and after, in the three arms with Application of Rolland Morris Questionnaires Application of Rolland Morris Questionnaires before and after intervention, this questionnaires assesses mild and moderate pain and disability 12 months
Primary Isolated comparative evaluation method, before and after, in the three arms, Application of Owestry Questionnaire Application of Owestry Questionnaire before and after intervention, this questionnaires evaluates more severe disabilities 12 months
Primary Isolated comparative evaluation method, before and after, in the three arms, Application analogue visual score for pain Application analogue visual score for pain before and after intervention, evaluates the level of pain according to the patient's reference 12 months
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